Trial Outcomes & Findings for Chewed Versus Integral Pill of Ticagrelor (NCT NCT03708588)
NCT ID: NCT03708588
Last Updated: 2024-10-03
Results Overview
Platelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA). This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
112 participants
Primary outcome timeframe
1 hour
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
Experimental: Chewed Ticagrelor
Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the percutaneous coronary intervention (PCI). Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg)
Ticagrelor: Chewed
|
Active Comparator: Integral Pill
Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the percutaneous coronary intervention (PCI). Patients will swallow the loading dose followed by 25-50mL (milliliters) of water. (180mg)
Ticagrelor: Integral
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
57
|
|
Overall Study
COMPLETED
|
46
|
48
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chewed Versus Integral Pill of Ticagrelor
Baseline characteristics by cohort
| Measure |
Experimental: Chewed Ticagrelor
n=46 Participants
Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg)
Ticagrelor: Chewed
|
Active Comparator: Integral Pill
n=48 Participants
Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg)
Ticagrelor: Integral
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
48 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Baseline PRU (P2Y12 platelet reaction units)
|
242.5 P2Y12 platelet reaction units
n=5 Participants
|
256 P2Y12 platelet reaction units
n=7 Participants
|
245 P2Y12 platelet reaction units
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hourPlatelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA). This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU.
Outcome measures
| Measure |
Experimental: Chewed Ticagrelor
n=46 Participants
Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg)
Ticagrelor: Chewed
|
Active Comparator: Integral Pill
n=48 Participants
Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg)
Ticagrelor: Integral
|
|---|---|---|
|
Concentration of Pharmacodynamics
|
142.5 platelet reaction units
Interval 31.0 to 230.0
|
210 platelet reaction units
Interval 97.5 to 278.5
|
SECONDARY outcome
Timeframe: 30 daysMeasure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding.
Outcome measures
| Measure |
Experimental: Chewed Ticagrelor
n=46 Participants
Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg)
Ticagrelor: Chewed
|
Active Comparator: Integral Pill
n=48 Participants
Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg)
Ticagrelor: Integral
|
|---|---|---|
|
Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearMeasure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding.
Outcome measures
| Measure |
Experimental: Chewed Ticagrelor
n=46 Participants
Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg)
Ticagrelor: Chewed
|
Active Comparator: Integral Pill
n=48 Participants
Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg)
Ticagrelor: Integral
|
|---|---|---|
|
Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)
|
4 Participants
|
2 Participants
|
Adverse Events
Experimental: Chewed Ticagrelor
Serious events: 6 serious events
Other events: 0 other events
Deaths: 2 deaths
Active Comparator: Integral Pill
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Experimental: Chewed Ticagrelor
n=46 participants at risk
Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg)
Ticagrelor: Chewed
|
Active Comparator: Integral Pill
n=48 participants at risk
Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg)
Ticagrelor: Integral
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Metastatic brain cancer
|
0.00%
0/46 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
2.1%
1/48 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
|
Cardiac disorders
Death - Intracerebral hemorrhage
|
2.2%
1/46 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
0.00%
0/48 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
|
General disorders
Death - Undetermined
|
2.2%
1/46 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
0.00%
0/48 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
|
General disorders
Inpatient hospitalization or prolongation of existing hospitalization
|
8.7%
4/46 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
4.2%
2/48 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
Other adverse events
| Measure |
Experimental: Chewed Ticagrelor
n=46 participants at risk
Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg)
Ticagrelor: Chewed
|
Active Comparator: Integral Pill
n=48 participants at risk
Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg)
Ticagrelor: Integral
|
|---|---|---|
|
Blood and lymphatic system disorders
Access site complication - Hematoma
|
0.00%
0/46 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
6.2%
3/48 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
|
Surgical and medical procedures
Urgent revascularization
|
0.00%
0/46 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
2.1%
1/48 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
|
Cardiac disorders
Postural hypertension without syncope
|
0.00%
0/46 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
2.1%
1/48 • Procedure (considered any time during procedure), post procedure (considered time after procedure and up to time of discharge), 30 day follow up, and 1 year follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place